FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Animal Drug Regs Amended for Recent Approvals

[ Price : $8.95]

Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for NADAs and ANADAs during...

Medtronic PMA Supplement for InterStim Micro/Leads

[ Price : $8.95]

Medtronic submits a PMA supplement for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.

Info Collection on IDE Reports/Records

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Investigational Device Exemptions Reports a...

FDA Monitors Heparin Makers Due to Swine Fever

[ Price : $8.95]

FDA says that heparin manufacturers are reporting that African swine fever in China is not affecting the drugs manufacturing and d...

Pfizer Licenses Investigational Antisense Therapy

[ Price : $8.95]

Pfizer licenses Akcea Therapeutics Akcea-AngPtl3-L, an investigational antisense therapy being developed for certain cardiovascula...

Pfenex NDA Approved for Forteo Copy

[ Price : $8.95]

FDA approves a Pfenex Inc. 505(b)(2) NDA for PF708 (teriparatide injection) that referenced Eli Lillys Forteo, indicated for treat...

Galderma Novel Topical OKd for Acne

[ Price : $8.95]

FDA approves a Galdermas Aklief (trifarotene) Cream for topically treating acne.

Mereo BioPharma Fast Track for Cancer

[ Price : $8.95]

FDA grants Mereo BioPharma Group fast track status for navicixizumab and its use for treating high grade ovarian, primary peritone...

ProTom Radiance 330 Proton System Cleared

[ Price : $8.95]

FDA clears a ProTom International Holding 510(k) for its Radiance 330 proton therapy system.

Panel to Review Jardiance sNDA

[ Price : $8.95]

Federal Register notice: FDA announces an 11/13 Endocrinologic and Metabolic Drugs Advisory Committee meeting to review a Boehring...